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A Study of LY3209590 in Participants With Type 2 Diabetes | Clinical Trials | Clareo Health

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A Study of LY3209590 in Participants With Type 2 Diabetes

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Patients With Type 2 Diabetes Mellitus

NCT03367377•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and tolerability of LY3209590 when given by injection under the skin to participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects will be documented. This study will last approximately 17 weeks, not including screening. Screening is required within 4 weeks prior to the start of the study.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year
•Have a glycated hemoglobin (HbA1c) greater than or equal to (≥) 7.0 percent (%) to less than or equal to (≤) 10.5% at screening
•Have had no episodes of severe hypoglycemia in the past 6 months
•Are on stable basal insulin (neutral protamine Hagedorn insulin suspension \[NPH\] insulin, insulin glargine \[U100 or U300\], or insulin detemir) with or without metformin, dipeptidyl peptidase IV (DPP-IV) inhibitors, sulfonylureas, and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, at a stable dose for at least 3 months before screening

Exclusion Criteria

•Have significant lipohypertrophy in the target abdominal injection
•Have a history of renal impairment
•Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children)
•Have proliferative retinopathy or maculopathy and/or severe neuropathy
•Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening
•Require daily insulin treatment less than (\<) 0.15 unit/kilogram (U/kg) per body weight
•Are treated with a continuous subcutaneous insulin infusion (CSII) pump
•Currently receiving degludec insulin therapy, or have been treated with degludec within the past 90 days

Locations (3)

Miami Research Associates

South Miami, Florida, United States

High Point Clinical Trials Center

High Point, North Carolina, United States

LMC Endocrinology Centres Ltd.

Toronto, Ontario, Canada

Key Dates

Start Date

January 3, 2018

Primary Completion Date

October 3, 2018

Completion Date

October 3, 2018

Last Updated

December 11, 2018

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

LY3209590

DRUG

Insulin Glargine

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY3209590 in Participants With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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